Table 3.

Drug-related treatment-emergent adverse events (%) (≥1% in the ferric carboxymaltose (FCM) group phase II/III database).³⁸

	FCM (n = 5799) (%)	Pooled comparators (n = 5272) (%)	Oral iron (n = 2497) (%)	Any intravenous iron (n = 2439) (%)	p-Valued
Nausea	3.1	2.8	2.5	2.2	0.112
Decreased blood phosphorus	1.9a	2a	0b	0b	<0.001
Injection site reaction	1.6a	0.7b	0c	1.8a	<0.001
Headache	1.4	1.1	1.1	1.3	0.453
Hypertension	1.3a	0.7b	0.1c	1.4a	<0.001
Dizziness	1.2a	0.8a	0.3b	1.3a	<0.001
Flushing	1.0a	0.1b,c	0b	0.2c	<0.001
Increased alanine aminotransferase	1.0a	0.5b,c	0.8a,c	0.2b	<0.001
Dysgeusia	0.9a	1.0a	0.2b	2.0c	<0.001
Constipation	0.8a	4.1b	8.0c	0.4a	<0.001
Vomiting	0.7	0.9	1.0	0.8	0.532
Diarrhea	0.5a	1.1b,c	1.6b	0.7a,c	<0.001
Hypotension	0.5a	0.8a	0b	1.7c	<0.001

^a,b,c Different letters represent statistical differences (p-value <0.05).

^dChi-square test.